International – Real-World Data Collection – What Role Could Your Device Play?

Real-world data collection enhances in-office visits and leads to better patient outcomes.

Doctors often ask their patients to follow specific instructions as part of their prescribed treatment and hope that they do so. However, physicians currently have few ways of tracking a patient’s compliance. They can only base their diagnoses and recommended course of action on what they observe and hear from the patient in the examination room.

When patients are asked to share their own accounts of their health condition and treatment progress, their reports can be limited or incomplete – it’s only human nature. Instead, real-world data should supplement the patient’s own report with additional information, improving the care they can receive and increasing the likelihood of a positive outcome.

With the help of technology, physicians could close the gap between in-office observations and the full picture of a patient’s health. The more accurate and complete information a doctor has, the more they are able to provide appropriate treatment.

FDA recognizes the potential of technology in this effort and is developing a framework to advance the collection of real-world data in the hopes of focusing medical studies on the point of care to provide the feedback that can improve the medical community’s diagnostic resources.

Collecting Patient Data

The more passive the data collection, the better. As soon as the patient is asked to follow directions and take a specific action, compliance declines by 25%. With each additional step, another 25%. Using technology in passive data systems may be the least-invasive medical solution for better treatment of patients. Examples of this are a connected insulin pump to measure blood sugar levels and deliver insulin in response, in-home motion sensors that can report on patient mobility, and a smarter version of something we all use every day, such as the Rochester Institute of Technology’s toilet seat with sensors that track a patient’s daily weight (which could indicate worsening congestive heart failure). None of these devices requires a change in patient routine or any deliberate action, potentially improving compliance and care for those who may not adhere well to their doctor-prescribed treatment.

By eliminating the need for a patient to alter their daily activities, passive data systems allow for non-invasive monitoring of medication or action adherence and health indicators…